The Effect of Kinesio® Tex Application on Pain, Functionality, Sleep Quality and Work Performance in Drivers

March 12, 2024 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
This study was planned to examine the effect of Kinesio® Tex application on pain, functionality, sleep quality and work performance in drivers experiencing neck-back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

50 active drivers will be included in the study. The drivers included in the study will be randomly divided into two groups as exercise group and taping group. The home exercise program will be visually explained to both groups and the exercises will be sent to the participants as video. Kinesio® Tex will also be applied to the banding group. Evaluations will be made before treatment and after 6 weeks of treatment. Within the scope of the evaluation, demographic information of the patients, work experience, daily working time, dominant hand, education information (university / high school), type of vehicle used, habit of leaning elbow on the left window, diseases and drugs used, smoking and alcohol use, given after mutual interview will be obtained by recording the answers. Joint range of motion, manual muscle test, pain severity of the individuals participating in the study with the Visual Analog Scale, neck functionality assessment with the Neck Disability Indicator, back functionality assessment with the Quebec Back-Low Back Pain Disability Scale, sleep quality assessment with the Pittsburgh Sleep Quality Index, work performance assessment To be assessed by the Work Role Functioning Questionnaire

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • İstanbul Büyükşehir Belediyesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Volunteering to participate in the study Having signed the voluntary consent form.
  • Being between the ages of 18-65
  • Working in home health services for at least 2 years
  • Reporting symptoms of localized pain and discomfort in the neck-back region lasting at least 1 week in the last 12 months

Exclusion Criteria:

  • The participant's wish to terminate the study
  • Receiving physical therapy for neck-back pain in the last 3 months
  • Findings such as pins and needles, numbness and tingling in the upper extremity
  • Having an allergy to taping
  • Presence of a known specific disease that may cause chronic neck-back pain (nerve root compression, postoperative condition in the neck and shoulder regions, peripheral entrapment neuropathy, cervical spine anomaly, severe neck trauma such as whiplash, malignancy, migraine).
  • Alcohol and drug addiction
  • Psychological conditions that may cause physical burden and recent major operations
  • Presence of a skin disease that will affect the neck and back area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
The exercise program to be given to the participants consists of stretching, strengthening and postural exercises for the muscles in the neck-back region. While doing the posture exercises, the participants will be asked to do the exercises in front of the mirror in order to correct the wrong postural posture and to provide relaxation.
Other: exercise
Stretching exercises for flexion, extension, lateral flexion and rotation, upper trapezius, levator scapula and pectoralis major muscles will be applied in the maximum range of motion of the cervical region in three planes. To increase the mobility of the thoracic region, exercises for thoracic mobility will be given. Strengthening exercises will focus on the back muscles. The resistance of the exercises will be determined according to the individual capacities and strain levels of the participants, and it will be requested to increase the amount of resistance applied depending on the functional developments. You will be asked to perform the exercises twice a day, with 10 repetitions, for 6 weeks. Participants will be asked to hold the position for 3-5 seconds and return to the starting position while doing the strengthening exercises.
Experimental: taping group
In addition to the exercises, the Kinesio® Tex taping application will remain on the body for 4 days, and then it will be applied 6 times in total, with a 3-day break.
Other: exercise
Stretching exercises for flexion, extension, lateral flexion and rotation, upper trapezius, levator scapula and pectoralis major muscles will be applied in the maximum range of motion of the cervical region in three planes. To increase the mobility of the thoracic region, exercises for thoracic mobility will be given. Strengthening exercises will focus on the back muscles. The resistance of the exercises will be determined according to the individual capacities and strain levels of the participants, and it will be requested to increase the amount of resistance applied depending on the functional developments. You will be asked to perform the exercises twice a day, with 10 repetitions, for 6 weeks. Participants will be asked to hold the position for 3-5 seconds and return to the starting position while doing the strengthening exercises.
Other: taping
After the Kinesio® Tex application, it will remain in the body for 4 days, and then it will be applied 6 times in total, with a 3-day break. It will be stated that the area to be banded should not contain substances such as cream, hair or oil. Upper Trapeze taping will be performed by applying one end of the Y tape to the upper trapeze and the other end to the lower part of the spina scapula, by affixing the tape to the head of the shoulder while standing upright, and keeping the participant's ear tilted towards the other ear as much as possible. Before attaching the rest of the tape, the participant will be asked to bring the shoulder blades closer together and stand upright. In this position, using a mechanical correction technique along the medial line of the scapula along the spine, the rest of the tape will be adhered as an I tape with 35-50% tension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Pain Disability Index Questionnaire
Time Frame: 8 weeks
The scale includes 10 titles. It includes pain sensitivity, heavy lifting, personal hygiene, reading, sleep, headache, concentration, work, driving, social activities. There are 6 answer options according to the severity of the limitation or pain. Scoring is between 0 and 5. The highest score is 50 and the least is 0. The neck disability level classification according to the total score is as follows 0-4: no restrictions 5-14: mild limitation 15-24: moderate limitation 25-34: severe limitation 34 and up: completely restricted
8 weeks
The Quebec Back Pain Disability Scale (QBPDS)
Time Frame: 8 weeks
The problems caused by back pain are evaluated with 20 different activities from the scale. Its rating is between 0-5. 0 points are expressed as "not difficult at all" and 5 points are expressed as "it is not possible to do". The total score is obtained by summing the answers given to the 20 activities.
8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 8 weeks
In the evaluation of the Pittsburgh Sleep Quality Index, 18 items are included in the scoring. The scale has a total of 7 components: sleep duration, habitual sleep efficiency, subjective sleep quality, sleep delay, sleep disturbance, daytime dysfunction, and sleep medication use. Some of the components consist of a single item, while others consist of groupings of several items. Each item scores between 0-3 and the sum of the scores of the 7 components forms the PSQI score. The total score is between 0-21. A high total score indicates a low sleep quality. A total PSQI score of ≤5 indicates "good sleep quality", and >5 indicates "poor sleep quality".
8 weeks
Work Role Functioning Questionnaire (WRFQ)
Time Frame: 8 weeks
The scale evaluates the difficulties experienced by people while doing their jobs as a percentage of time. In addition, the questionnaire evaluates the effectiveness of the treatment applied. It has five sub-headings as work program (5 questions), Efficiency (7 questions), Physical (6 questions), Mental (6 questions) and Social status (3 questions). It is a scale with 27 questions in total. This scale assesses how often individuals have had difficulties while doing their jobs in the last four weeks. If the expression defined in the question is not related to the profession of the person, he is asked to mark the option "It is not suitable for my profession".
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Investigators

  • Study Chair: Hakan ZENGİ, Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 12, 2023

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uskudar73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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